U.S. patent application number 12/594835 was filed with the patent office on 2010-06-24 for device for transcutaneous biopsy.
Invention is credited to Odoardo Buressiniani.
Application Number | 20100160827 12/594835 |
Document ID | / |
Family ID | 39709339 |
Filed Date | 2010-06-24 |
United States Patent
Application |
20100160827 |
Kind Code |
A1 |
Buressiniani; Odoardo |
June 24, 2010 |
DEVICE FOR TRANSCUTANEOUS BIOPSY
Abstract
A biopsy device includes a first hollow cylindrical element, a
second hollow cylindrical element inside which the first hollow
cylindrical element is insertable and a locking element that is
suitable for locking a tissue sample inside the first hollow
cylindrical element. The locking element includes a deformable
portion of the first hollow cylindrical element that is able to
become deformed to enable a cross section of the first hollow
cylindrical element to be closed, the deformable portion connecting
a distal end of the first hollow cylindrical element to a body of
the first hollow cylindrical element.
Inventors: |
Buressiniani; Odoardo;
(Roma, IT) |
Correspondence
Address: |
LAUBSCHER & LAUBSCHER, P.C.
1160 SPA ROAD, SUITE 2B
ANNAPOLIS
MD
21403
US
|
Family ID: |
39709339 |
Appl. No.: |
12/594835 |
Filed: |
April 7, 2008 |
PCT Filed: |
April 7, 2008 |
PCT NO: |
PCT/IB08/00827 |
371 Date: |
January 27, 2010 |
Current U.S.
Class: |
600/567 |
Current CPC
Class: |
A61B 10/025 20130101;
A61B 2010/0258 20130101; A61B 2017/32004 20130101; A61B 10/0266
20130101; A61B 2017/320064 20130101; A61B 10/0275 20130101 |
Class at
Publication: |
600/567 |
International
Class: |
A61B 10/02 20060101
A61B010/02 |
Foreign Application Data
Date |
Code |
Application Number |
Apr 6, 2007 |
IT |
RM2007A000196 |
Claims
1. (canceled)
2. (canceled)
3. (canceled)
4. (canceled)
5. (canceled)
6. (canceled)
7. (canceled)
8. (canceled)
9. (canceled)
10. A biopsy device, comprising a first hollow cylindrical element,
a second hollow cylindrical element inside which said first hollow
cylindrical element is insertable and a locking element capable of
locking a tissue sample inside said first hollow cylindrical
element, said locking element comprising a deformable portion of
said first hollow cylindrical element that is able to become
deformed to enable a cross section of said first hollow cylindrical
element to close, said deformable portion connecting a distal end
of said first hollow cylindrical element to a body of said first
hollow cylindrical element, said deformable portion comprising a
plurality of ribs that connect said distal end to said body,
wherein said second hollow cylindrical element comprises a fixing
element suitable for locking an advance of said first hollow
cylindrical element inside said second hollow cylindrical element
in the direction of a distal end of said second hollow cylindrical
element.
11. A device according to claim 10, wherein the ribs of said
plurality of ribs are arranged with a substantially constant
angular pitch along a circumference of the first hollow cylindrical
element.
12. A device according to claim 10, wherein said fixing element
comprises a tapered distal end of said second hollow cylindrical
element.
13. A device according to claim 10, wherein said fixing element
comprises a weld that connects a portion of internal surface of a
distal end of the second hollow cylindrical element to a
corresponding portion of external surface of the distal end of the
first hollow cylindrical element.
14. A device according to claim 10, wherein said fixing element
comprises a protuberance that protrudes inside the second hollow
cylindrical element reducing the cross section thereof locally.
15. A device according to claim 10, wherein the ribs of at least a
pair of ribs of said plurality of ribs are interrupted by
respective notches.
Description
[0001] The present invention relates to a transcutaneous biopsy
device for both soft tissue and bone marrow tissue, which is also
known as rigid tissue, in particular the present invention relates
to a device for taking samples of organic tissue from the body of a
patient.
[0002] In the prior art needle devices are known for the
transcutaneous biopsy of rigid tissue, comprising a needle in the
shape of a hollow cylinder, with a variable diameter and length, an
end of which, said proximal end, is provided with a grip suitable
for enabling the operator to manoeuvre the needle, whilst the other
end, said distal end, is provided with a cutting edge that is
suitable for enabling the sample of tissue to be taken to be
separated at least partially from the surrounding tissue.
[0003] The needle is generally coupled with a spindle consisting of
a steel rod of dimensions such as to be able to slide inside the
needle. Said rod is provided with a sharpened end that protrudes
from the distal end of the needle and is intended for perforating
the particularly hard surface layer of the bone tissue to reach the
marrow tissue.
[0004] The biopsy is conducted by pushing and rotating the needle
through the skin and the muscle bundles of the patient until the
sharp end of the spindle reaches the bone and perforates the
surface layer, reaching the marrow tissue.
[0005] At this point the spindle is extracted from inside the
hollow needle and the needle is pushed further, advancing and
rotating inside the marrow tissue, so that the cutting distal end
of the needle isolates an approximately cylindrical portion of
tissue from the surrounding tissue and surrounds the approximately
cylindrical portion in the interior thereof: this portion of the
tissue constitutes the bioptic sample to be taken. The aforesaid
sample remains connected to the surrounding tissue at the distal
end thereof, i.e. at the end facing the outside of the needle.
[0006] At this point, in order to cause the sample to be detached,
the so-called dislocation step is performed that essentially
consists of performing rotation and oscillation of the needle in a
direction that is substantially perpendicular to the longitudinal
axis thereof; after performing this manoeuvre and then after
causing the sample to detach completely at the distal end thereof
the needle is extracted from the patient.
[0007] This manoeuvre in general creates significant trauma for the
patient, inasmuch as the oscillating movements impressed on the
needle cause numerous microfractures to the bone tissue, which
cause considerable suffering in the patient and extend healing time
thereof.
[0008] Further, there is no guarantee that after this manoeuvre has
been performed the sample will actually be taken. It is in fact
possible that the distal part of the sample has not been completely
detached from the surrounding tissue and that therefore, during
extracting of the hollow needle, it remains inside the body, or
that although complete detachment of the sample from the
surrounding tissue has been obtained there is a distal portion of
the sample that partially protrudes from the distal end of the
needle, during extraction this portion may become damaged or
facilitate the total loss of the sample, inside the body; in both
the disclosed situations it is necessary to repeat the sampling
operation, with consequent significant deterioration of the trauma
and of the suffering caused to the patient.
[0009] Devices are further known for transcutaneous biopsy of rigid
tissues, comprising a needle and a spindle with the same features
as those disclosed previously, in which the needle is tapered at
the distal end thereof.
[0010] These devices comprise locking elements to be inserted
slidingly through the proximal part of the needle, after the latter
has been inserted into the body of the patient and the interior
thereof encloses a tissue sample to be taken.
[0011] These locking elements are shaped so as to be able to be
inserted between a zone of the internal wall of the needle and the
tissue sample comprised therein.
[0012] When the locking element is pushed as far as the tapered end
portion of the hollow cylinder it is deflected radially to the
inside so as to force the tissue sample against the opposite
internal wall zone of the hollow needle.
[0013] This causes a certain sample locking force to be created
between a part of the locking element and the internal wall of the
needle.
[0014] This locking force, during the needle-extracting step,
avoids the dislocation manoeuvre disclosed previously; it is
possible to obtain complete detachment of the sample at the distal
end thereof from the surrounding tissues by rotation of the needle,
preventing oscillations that create the aforementioned
microfractures in the bone tissue. Nevertheless, this type of
device has significant drawbacks.
[0015] Inserting the needle-locking element is very delicate as it
can often damage the penetrated sample at the distal end of the
needle, through crushing or rubbing; the removed but damaged tissue
may create artefacts during clinical evaluation thereof and so the
patient is forced to undergo again a biopsy with consequent
significant deterioration of the trauma and of the suffering
caused.
[0016] The locking force that is created through the effect of the
friction between the sample, the locking element and the internal
wall of the hollow needle may not be sufficient to clamp the
sample. In these situations the effect of the rotations given to
the needle may not have the hoped-for effect and it may therefore
be impossible to take the sample. Another negative condition that
may occur due to insufficient locking force is the loss of the
sample from the internal cavity of the needle during extracting. In
this situation it is possible to lose the sample inside the tissues
that the hollow needle passes through before being removed.
[0017] Evaluating a correct locking force would necessarily require
having to know exactly the nature of the sample, defined as
physical and mechanical features of the organic tissue, and above
all the surrounding conditions that obtain near the tissue to be
removed such as greater or lesser blood flow. The combination of a
particular tissue with greater or lesser blood flow may cause a
greater or lesser friction coefficient between the sample, the
walls of the locking element and the walls of the needle, creating
greater or lesser friction force and thus a greater or lesser
locking force. If during a biopsy the locking force is
insufficient, the result is the failure to take the sample, which
implies, as already said, having to repeat the operation and thus a
situation of further discomfort for the patient.
[0018] From the prior art other devices are known consisting of a
needle, a spindle and a locking element with the latter, having
peculiar features that attempt to resolve in part the disclosed
difficulties.
[0019] Some devices exploit exactly the same operating principle
disclosed above, with the sole teaching of having the locking
element reinserted inside the hollow needle, in this way, the risk
of damaging the tissue sample contained inside the needle is
avoided, but all the other disclosed drawbacks remain.
[0020] Often, in order to increase locking force and thus increase
the percentages of successful sampling, the locking element may
have the distal end shaped as a coil and can be provided with
independent driving means. Once the tissue sample has been
introduced inside the needle, it is possible to tighten the distal
zone of the spiral-shaped locking element by driving means
connected to the locking element, in this way friction force is
created between the tissue and the distal part of the locking
element. This solution, like many others similar thereto can on the
one hand ensure greater clamping, reducing, but not eliminating the
risks disclosed above, on the other hand it increases the risk of
spoiling the sample in the locking step. In fact, a spiral shape or
other geometrical shapes that are similar thereto can cause damage
to the sample distributed over all the surface thereof, which
leads, as already said, to a series of artefacts being obtained
during the clinical valuation step and then to the biopsy being
consequently repeated.
[0021] From the prior art needles are known for transcutaneous
biopsy on soft tissues such as, for example, pulmonary tissue,
tissue constituting organs such as the prostrate, the liver, etc.
These devices consist of a spindle that is substantially
cylindrical to the end of the tip from which a housing is
obtained--for example by obtaining a levelling along a portion of
the spindle--suitable for receiving the sample to be taken, and of
a hollow needle with a cutting tip, slidingly coupled outside said
spindle.
[0022] The housing has dimensions such as to receive a tissue
sample of a sufficient size for the histological examinations to be
conducted thereupon.
[0023] In order to conduct the biopsy, the instrument is introduced
into the body of the patient with the spindle retracted inside the
hollow needle so that only the tip protrudes therefrom.
[0024] When the tip of the spindle has reached the zone of the body
of the patient from which the sample has to be taken, the spindle
is made to exit the needle by reciprocal axial sliding. In this
way, a portion of tissue surrounding the spindle rests on the
housing obtained on the spindle.
[0025] At this point the hollow needle is moved until it covers
said housing so that the cutting tip of the hollow needle separates
from the surrounding tissue, with a guillotine action, the portion
of tissue that has penetrated into the aforesaid housing.
[0026] These needles have the drawback that a sufficient quantity
of tissue does not always enter the aforesaid housing for a bioptic
examination, so the taking of the tissue sample often has to be
repeated, with consequent discomfort for the patient.
[0027] The present invention proposes providing a device for
transcutaneous biopsy of both hard and soft tissues, which is
completely free of all the aforesaid drawbacks and which enables
the suffering of the patient to be minimised who has to submit to a
bioptic intervention.
[0028] According to the present invention a biopsy device is
provided, comprising a first hollow cylindrical element, a second
hollow cylindrical element inside which said first hollow
cylindrical element is insertable and locking means that is
suitable for locking a tissue sample inside said first hollow
cylindrical element, characterised in that said locking means
comprises a deformable portion of said first hollow cylindrical
element, that is able to become deformed to enable a cross section
of said first hollow cylindrical element to be closed, said
deformable portion being arranged near a distal end of said first
hollow cylindrical element.
[0029] This closure ensures secure and complete detachment both of
a soft tissue sample and a bone-marrow tissue sample, that is
inside said second hollow cylindrical element, eliminating the
risks of damage to the sample. Conceptually, compared with what is
described and present in the prior art, this locking element does
not intend to exploit the friction force between the tissue and the
walls thereof as a clamping force, but acts in a mechanical manner,
simply reducing to zero a zone of the tissue entry section.
[0030] The invention can be better understood and implemented with
reference to the following description that is given purely by way
of non-limiting example, and with reference to the attached
drawings, in which:
[0031] FIG. 1 shows a longitudinal and frontal view of a first
hollow cylindrical element 1 of a biopsy device according to the
invention. The first hollow cylindrical element 1 comprises a body
1A having a distal end 1C connected to the body 1A by a portion 1B
shaped in such a manner as to obtain a pair of ribs 2 constituting
a locking element, that through deformation closes a cross section
of the first hollow cylindrical element 1.
[0032] FIG. 2 shows another longitudinal view of the first hollow
cylindrical element in which the ribs 2 are clearly visible, also
in the Figure a section of the distal end 1C of the first hollow
cylindrical element 1 is shown in which the sections of the ribs 2
are shown.
[0033] FIG. 3 is a longitudinal view of the first hollow
cylindrical element 1, with the ribs 2 of the portion 1B in a
deformed configuration in which they enclose a cross section of the
first hollow cylindrical element 1.
[0034] FIG. 4 is a longitudinal section of the first hollow
cylindrical element 1 inside which there is comprised a tissue
sample 3 the distal end of which is still connected to the
surrounding tissues 4.
[0035] FIG. 5 is a longitudinal section of the first hollow
cylindrical element 1 inside which a tissue sample 3 has been
enclosed and to which portion 1B a deforming force has been applied
that has placed the ribs 2 in the deformed configuration, in which
the detachment of the tissue sample 3 is obtained in the closing
zone of the cross section of the first hollow cylindrical element
1.
[0036] FIG. 6 is a schematic view that illustrates the way in which
the ribs 2 of the first hollow cylindrical element 1 can be
deformed. The deformation is obtained by locking the distal end 1C
of the first hollow cylindrical element 1 by a fixing element 5,
that prevents said distal end 1C from moving, and applying to the
first hollow cylindrical element 1 an axial thrust that compresses
the axial thrust in the direction of said thrust so as to place the
ribs 2 in the deformed configuration;
[0037] FIG. 7 is a longitudinal section of an embodiment of a
biopsy device according to the invention comprising the first
hollow cylindrical element 1, inserted inside a second hollow
cylindrical element 6, so as to be able to slide in relation
thereto. The second hollow cylindrical element 6 is provided with a
tapered distal end 5A that constitutes the fixing element that acts
as a block to the advance of the first hollow cylindrical element 1
when an axial thrust is applied thereto that is directed to the
distal end 1C thereof; the combined effect of the fixing element 5A
and of the axial thrust is to take the ribs 2 in deformed
configuration to separate a tissue sample from the surrounding
tissue and lock the sample tissue inside the first hollow
cylindrical element 1.
[0038] FIG. 8 is a longitudinal section that is similar to that of
FIG. 7, that illustrates a further embodiment of a biopsy device
according to the invention in which the fixing element consists of
a weld 5B by means of which a portion of internal surface of the
distal end of the second hollow cylindrical element 6 is welded
with a corresponding portion of external surface of the distal end
1C of the first hollow cylindrical element 1. This weld 5B, by
preventing the first hollow cylindrical element 1 from sliding
axially with respect to the second hollow cylindrical element 6
means that, by applying to the first hollow cylindrical element 1
an axial thrust directed to the distal end 1C thereof, the ribs 2
are taken to the deformed configuration to separate a tissue sample
from the surrounding tissue and lock the tissue sample inside the
first hollow cylindrical element 1.
[0039] FIG. 9 is a longitudinal section like the one in FIGS. 7 and
8 that illustrates a still further embodiment of a biopsy device
according to the invention in which the fixing element consists of
a protuberance 5C that protrudes inside the second hollow
cylindrical element 6, reducing the cross section thereof locally,
so as to constitute a lock to the advance of the first hollow
cylindrical element 1, when axial thrust is applied thereto that is
directed to the distal end 1C thereof; the combined effect of the
protuberance 5C and of the axial thrust is to take the ribs 2 to
the deformed configuration thereof to separate a tissue sample from
the surrounding tissue and lock the tissue sample inside the first
hollow cylindrical element 1.
[0040] FIG. 10 is a longitudinal and section view like the one in
FIG. 2 that illustrates an embodiment of the device according to
the invention in which a plurality of ribs 2A is provided, for
example three, arranged with a substantially constant angular pitch
along the circumference of the first hollow cylindrical element 1,
in said portion 1B.
[0041] FIG. 11 is a longitudinal and section view like the one in
FIG. 10 that illustrates an embodiment of the device according to
the invention in which four ribs 2B are provided that are arranged
with a substantially constant angular pitch along the circumference
of the first hollow cylindrical element 1, in said portion 1B.
[0042] FIG. 12 is a longitudinal view like the one in FIG. 11 that
illustrates the deformed configuration of the ribs 2B, to separate
a tissue sample from the surrounding tissue and lock the tissue
sample inside the first hollow cylindrical element 1.
[0043] FIGS. 13, 14, 15 are longitudinal views of the first hollow
cylindrical element 1 that show some possible geometrical shapes of
the ribs, indicated by the reference numbers 2C, 2D and 2E. These
configurations 2C, 2D, and 2E are distributed by way of
non-limiting example to illustrate that the geometry of the ribs is
not binding to be able to obtain the deformed configuration
thereof.
[0044] FIGS. 16 to 17 are also longitudinal views of the first
hollow cylindrical element 1 that show some further possible
geometries of the ribs, indicated by the reference numbers 2F, and
2G, in these further geometries at least a pair of ribs 2F, 2G are
interrupted by a notch 7.
[0045] FIGS. 18 and 19 are views like the one in FIG. 17, rotated
by 90.degree. with respect thereto around the longitudinal axis of
the first hollow cylindrical element 1, to show, respectively, the
undeformed configuration and the deformed configuration of the ribs
2G.
[0046] Also the geometries of the ribs 2F and 2G illustrated in
FIGS. 16 to 19 are given by way of non-limiting example and to
illustrate that also the geometry of the ribs even with the
presence of notches 7 is not binding to be able to obtain the
deformed configuration thereof.
* * * * *